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New global recommendations: A multidisciplinary approach to improving outcomes in diabetes
p r i m a r y c a r e d i a b e t e s 1 ( 2 0 0 7 ) 49–55
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Opinion
New global recommendations: A multidisciplinary approach to improving outcomes in diabetes Margaret McGill a,∗ , Anne-Marie Felton b , on behalf of the Global Partnership for Effective Diabetes Management a b
Diabetes Centre, Royal Prince Alfred Hospital, Sydney, NSW, Australia Federation of European Nurses in Diabetes, 24 Holmesdale Avenue, London, SW14 7BQ, UK
a r t i c l e
i n f o
a b s t r a c t
Article history:
Up to two-thirds of people with type-2 diabetes do not achieve glycaemic targets, increasing
Received 21 April 2006
their risk of serious complications. New global recommendations from The Global Partnership
Accepted 28 July 2006
for Effective Diabetes Management offer practical, simple advice for the diabetes management
Published on line 19 December 2006
team to help individuals reach glycaemic goals. The recommendations focus on four areas: achieving optimal glycaemic control, targeting the underlying pathophysiology of the dis-
Keywords:
ease, treating earlier and intensively with combination therapy, and adopting a holistic
Type-2 diabetes mellitus
approach. This article reviews the new recommendations and suggests that they offer a
Hyperglycemia
route to achieving guideline-based targets and improving outcomes in the real-life health-
Diabetes complications
care setting.
Interdisciplinary health team
© 2006 Published by Elsevier Ltd on behalf of Primary Care Diabetes Europe.
Nurses Nurse patient relations Multidisciplinary communication Education
1.
Introduction
The magnitude of the challenge that diabetes presents to health services is strikingly clear. Diabetes is now the fourth or fifth leading cause of death in most developed countries, and with 194 million people suffering from the disease worldwide, its incidence is approaching epidemic proportions [1]. Type2 diabetes, which accounts for around 90–95% of all cases of diabetes [2] is characterised by insulin resistance and is often associated with obesity [3,4]. Consequently, the incidence of type-2 diabetes is projected to increase as populations age,
∗
urbanisation increases, diets become ‘westernised’ and levels of physical activity decrease [5]. By 2030, the International Diabetes Federation predicts that more than 330 million people will have diabetes worldwide [1]. While the direct symptoms of type-2 diabetes, such as thirst, frequent urination and fatigue, can be mild and may cause little interruption to activities of daily living, it is the complications of the disease, including vascular disease, kidney disease and nerve damage, that result in substantial morbidity and mortality. Hospitalisations for complications account for more than half of the healthcare costs of type-
Corresponding author. E-mail address: [email protected] (M. McGill). 1751-9918/$ – see front matter © 2006 Published by Elsevier Ltd on behalf of Primary Care Diabetes Europe. doi:10.1016/j.pcd.2006.07.004
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p r i m a r y c a r e d i a b e t e s 1 ( 2 0 0 7 ) 49–55
2 diabetes [6], and three-quarters of people with diabetes die from cardiovascular disease [7]. The development of both micro- and macrovascular complications is associated with elevated blood glucose, with research suggesting that the risk of serious complications increases with the length of time blood glucose is uncontrolled [8,9]. Importantly, evidence shows that people who achieve a period of good control soon after diagnosis of type-2 diabetes have a lower risk of complications later in disease, even if their control subsequently decreases [10–12]. This concept, known as ‘metabolic memory’, suggests that not only is good glycaemic control important, but that good control should be achieved as early as possible. Fundamental to the role of the diabetes multidisciplinary professional management team is the development of initiatives to help people with diabetes achieve glucose goals and reduce the risk of complications. The team must ensure that humanity and continuity of individualised care is central to such initiatives. In recent years, the team structure has changed in many healthcare systems to reflect changes in the model of care. There has been a shift from the traditional, physician-led ‘acute-care model’, in which there is little involvement of the individual with diabetes and team members are often primarily task-oriented, to a ‘chronic care model’, where all members of the team are equal and interdependent, and the person with diabetes plays an active role in daily management. In many, but not all cases, diabetes specialist nurses are the primary point of contact for people with diabetes. Their role is underpinned by increasingly specialised knowledge and skills and, in some systems, the ability to make autonomous diagnoses and treatment decisions. This article reviews new recommendations published by the Global Partnership for Effective Diabetes Management [13], which are designed to help individuals with type-2 diabetes meet glycaemic targets and so improve treatment outcomes.
2. The new recommendations: meeting a need Guidelines around the world generally focus on the importance of achieving HbA1c of 6.0–7.0% [14–18]. However, despite
these guidelines, only one-third of individuals with diabetes reach their recommended HbA1c goal [19,20]. This contrasts with the situation in other areas such as dyslipidaemia, where three-quarters of people reach low density lipoprotein (LDL)-cholesterol treatment goals [21]. The need for optimal glycaemic control is emphasised by results from the EPICNorfolk study, in which the risk of death from all causes, and from heart disease in particular, rose with increasing HbA1c concentration at all levels (Fig. 1) [22]. This study also demonstrated that reducing HbA1c by just 0.2% in the general population could reduce overall mortality by 10% [22]. Therefore, it is clear that more action is needed to improve the proportion of individuals with type-2 diabetes who achieve target glycaemic control, and to enable this to happen as soon as possible after diagnosis. The Global Partnership for Effective Diabetes Management is a group of international diabetes experts that is multidisciplinary and, as such, includes primary-care physicians, specialist nurses and diabetologists amongst its members. The group’s aim is to provide guidance and support for diabetes management teams to help more people reach blood glucose goals. Their recommendations are different because they are the first to be developed specifically to address the gap that exists between current guidelines and implementation in the clinical practice setting by offering practical, easy-to-use advice on how to get people to glucose goals.
2.1.
Barriers to effective glucose control
The new recommendations identify a number of barriers that may account for the proportion of individuals who do not reach glycaemic goals [13]. One major barrier is the fact that diabetes management is traditionally conservative and many prescribers are wary of treating too intensively or using new approaches for fear of side effects. In addition, diabetes is a complex condition for which many treatments exist, polypharmacy is required and it is not always easy to be aware of latest developments. Moreover, prescribers often rely on the ‘stepwise’ approach to treatment, in which management begins with diet and exercise, followed by introduction of monotherapy, increase of the monotherapy to the maximum recommended dose and, finally, combination therapy
Fig. 1 – HbA1c and risk of cardiovascular events or death [22]. A prospective population study of 4662 men and 5570 women aged 45–79 years from the EPIC-Norfolk study. Average follow-up time was 6 years. CHD: coronary heart disease; CVD: cardiovascular disease.
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[23]. However, the stepwise approach can cause unnecessary (or prolonged) delays in reaching glucose goals. Evidence suggests that individuals treated with monotherapy often have HbA1c ≥8% for an average of 14.5–20.5 months before the treatment is changed or a new treatment is added [24,25]. Another barrier is the perception among some prescribers that treatments lack efficacy. While there is a need for efficacious agents, poor adherence, due to a number of financial and behavioural reasons, may contribute to this perception. Adherence to oral glucose-lowering medicines is known often to be lower than in other disease areas, possibly due to: adverse events associated with medication; social, cultural or economic barriers; or a lack of confidence in the benefits of adherence [26]. Moreover, type-2 diabetes is a progressive disease that requires polypharmacy to achieve target blood glucose levels and this concept may not readily be appreciated by some health professionals who persist with advice on lifestyle modification without changes in pharmacotherapy. Also contributing to a perceived lack of efficacy are the logistical difficulties and high demands on time and resources facing healthcare professionals, which can impact on the quality of the patient-provider consultation. A lack of knowledge about the underlying pathophysiology of type-2 diabetes, and particularly, the need to address the insulin resistance that is present in 80–85% of people with type-2 diabetes, can also act as a barrier to glycaemic control [27,28]. Many commonly used therapies that improve glycaemic control on a short-term basis do not address insulin resistance adequately [27–29]. The new recommendations were formulated with these barriers in mind and having considered the pressures on diabetes management teams.
3.
A practical call to action
The 10 key practical recommendations of the Global Partnership are shown in Table 1 [13]. The recommendations cover four key areas: achieving optimal blood glucose control, treating earlier and intensively with combination therapy, targeting the underlying pathophysiology of type-2 diabetes, and adopting a holistic approach that improves patients’ understanding. Uniting the four areas is an underlying sense of urgency about the need to act proactively to bring glycaemia under control. The ability to implement all 10 recommendations may depend
51
on the local situation and resources, but the Global Partnership hopes that healthcare professionals will “recognise the importance of tight glycaemic control and implement or adopt as many recommendations as is feasible locally”.
3.1.
Achieving optimal glycaemic control
Current guidelines differ in their recommendations for target glycaemic control [14–18] so the Global Partnership suggests that a universal goal would simplify and improve patient management. Data from the United Kingdom Prospective Diabetes Study (UKPDS) indicated that every 1% drop in HbA1c reduces the overall risk of complications of type-2 diabetes by 21% [9]. Importantly, there was no lower threshold below which a reduction in HbA1c was no longer beneficial. Consequently, the recommendations state that management should aim for HbA1c <6.5%, in line with the latest guidelines from the International Diabetes Federation [30]. They also note the importance of regular monitoring of blood glucose, recommending that HbA1c is monitored every 3 months in addition to regular self-monitoring and that two consecutive measurements of HbA1c ≥7.0% should lead to a review of treatment. Self-monitoring can allow individuals to become more proactive and to improve their glucose control [31], but it is important that results are discussed regularly between members of the diabetes management team so that they are aware of the significance of the results and can assist the individual to take appropriate action.
3.2. Treating earlier and intensively with combination therapy The delays in achieving glycaemic control associated with stepwise management or an over-reliance on lifestyle intervention alone have led the new recommendations to focus on a more proactive approach. They recommend earlier use of combination therapy in parallel with diet and exercise reinforcement. A regimen in which glycaemia is monitored regularly and treatment is reviewed if an individual is not at goal can allow more rapid attainment of glycaemic control and may avoid side effects that are associated with some highdose monotherapies [32,33]. For example, newly-diagnosed individuals should be treated intensively with the aim of achieving HbA1c <6.5% within 6 months of diagnosis. For those
Table 1 – Ten steps to get more type-2 diabetes patients to goal 1 2 3 4 5 6 7 8 9 10
∗
Aim for good glycaemic control, defined as HbA1c < 6.5%* Monitor HbA1c every 3 months in addition to regular glucose self-monitoring Aggressively manage hyperglycaemia, dyslipidaemia and hypertension with the same intensity to obtain the best patient outcome Refer all newly diagnosed patients to a unit specialising in diabetes care where possible Address the underlying pathophysiology, including treatment of insulin resistance Treat patients intensively so as to achieve target HbA1c <6.5%* within 6 months of diagnosis After 3 months, if patients are not at target HbA1c <6.5%* , consider combination therapy Initiate combination therapy or insulin immediately for all patients with HbA1c ≥9% at diagnosis Use combinations of oral antidiabetic medications with complementary mechanisms of action Implement a multi- and inter-disciplinary team approach to diabetes management to encourage patient education and self-care and share responsibility for patients achieving glucose goals
Or fasting/preprandial plasma glucose <110 mg/dl (6.0 mmol/l) where assessment of HbA1c is not possible.
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Fig. 2 – Global Partnership recommendations for management of glycaemia in newly diagnosed individuals [13]. Reproduced from Del Prato S et al. Improving glucose management: ten steps to get more patients with type 2 diabetes to goal. Recommendations from the Global Partnership for Effective Diabetes Management, International Journal of Clinical Practice, with permission from Blackwell Publishing.
who are not at goal after three months, combination therapy should be considered in order to reach the 6-month goal. For individuals who have particularly high blood glucose at diagnosis (HbA1c ≥9%), consideration should be given to initiating combination therapy immediately, or in some cases temporary use of insulin therapy (before transfer to mono- or combination oral therapy) in order to reduce glucose toxicity and reach glycaemic goals as soon as possible. The recommended treatment paradigm for newly-diagnosed individuals is shown in Fig. 2. Lifestyle therapy can be effective and should be an integral component of diabetes care at all times [34]. However, in the real-life setting, adherence to diet and exercise can be difficult to maintain. Because delays in introducing oral monotherapy (often seen with the stepwise approach) can increase the length of time it takes to reach glycaemic goal, the Global Partnership recommends that lifestyle changes are initiated in tandem with pharmacological therapy.
3.3. Targeting the underlying pathophysiology of type-2 diabetes—insulin resistance and progressive ˇ-cell failure The basic pathological mechanisms in type-2 diabetes are insulin resistance leading to pancreatic stress and, in susceptible individuals, consequent pancreatic -cell failure. To date, while glucose-lowering medications are successful in reducing blood glucose levels in the short term, they have not been able to prevent the progressive natural history of type-2 diabetes, as demonstrated by the continual loss of -cell function over time [35]. To optimise chronic glycaemia, the Global Partnership recommends that treatments should address the underlying pathophysiology of the disease to increase insulin sensitivity and/or potentiate insulin secretion. Therapies used in combination should ideally have complementary actions. For example, a thiazolidinedione with a sulphonylurea addresses both defects of insulin resistance and insulin secretion, respectively. Alternatively,
metformin mainly improves hepatic insulin resistance while thiazolidinediones mainly function through adipose tissue and skeletal muscle as insulin-sensitising agents, indicating the value of such a combination [36]. Triple oral therapy with each of these agents also has significant rationale. The comorbidities that contribute to the complications of type-2 diabetes should also be addressed alongside the disease itself. Treating comorbidities with equal priority may redress the balance between the proportion of individuals reaching goals for areas such as LDL-cholesterol and blood pressure, and the relatively low proportion reaching glycaemic goals [19–21]. The Global Partnership recommends that hyperglycaemia, dyslipidaemia and hypertension are managed rigorously with equal intensity to obtain the best outcome.
3.4. Adopting a holistic approach that improves patient understanding The Global Partnership recommends that a multi- and interdisciplinary team approach is the sine qua non of diabetes management, with the aim of encouraging therapeutic, structured patient education and self-care so that responsibility for achieving agreed glucose goals is shared. The key principle of the multidisciplinary team is that all members of the team are equal and interdependent. Hence, there is often some flexibility of professional boundaries, rather than the more distinct roles seen in the hierarchical teams of the past. In the chroniccare model, people undergoing treatment are no longer passive, and instead play an equal and active role in their management and in setting their own goals based on what they want to achieve. The team approach enables continuity of care and self-management and, with adequate communication, all members of the team – including the person with diabetes – can be unified and work towards the same goal. Evidence is building to support the benefits of this model. A study that compared a nurse-led multidisciplinary team (involving a diabetes specialist nurse, psychologist, nutritionist and pharmacist) with standard diabetes care over 6
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Fig. 3 – Impact of a multidisciplinary team [37]. * P < 0.001 compared with control (6-month intervention period). † P = 0.04 compared with control (17–18 months after randomisation). Control: n = 88; multidisciplinary team: n = 97. Copyright ©American Diabetes Association. From Diabetes Care, vol. 22 (1999) 2011–2017. Reprinted with permission from The American Diabetes Association.
months in a primary-care setting found that HbA1c levels decreased by 1.2% with the multidisciplinary approach, but only 0.2% in the control group [37]. During the 17–18 months after randomisation, hospital admissions were 80% lower in the multidisciplinary group (Fig. 3) [37]. Additional research suggests that, if properly implemented, the multidisciplinary approach is cost-effective and improves the quality of diabetes care compared with individual patient-provider care [38]. When a multidisciplinary team approach is taken the exact structure usually varies depending on the local circumstances; however, common to all teams is the position of the person with diabetes at the centre. Ideally, the team will include three or four healthcare professionals with complementary skills: for example, a diabetologist/physician, a diabetes specialist nurse, a dietician and a podiatrist [39]. In some cases the team may extend to include other specialist support services such as cardiologists, exercise physiologists, nephrologists, neurologists, ophthalmologists, wound-care specialists or social workers. In some countries, units that specialise in diabetes care are becoming more common, and evidence suggests that access to such services can increase the proportion of people with diabetes achieving treatment goals and increase survival rates [40]. Consequently, the Global Partnership recommends that all newly diagnosed individuals have access to the variety of clinical and education services offered by a unit specialising in diabetes care where they are available [13]. The continued education and training of all members of the team is an essential component of diabetes care. People with diabetes live with their condition 24 h a day and inevitably undertake 95% of their own care. Consequently, one of the important aims of therapeutic education is to encourage selfmanagement where possible. Individuals must be equipped with the knowledge, skills and confidence to take an active role in managing their condition. Furthermore, people with diabetes should be educated by healthcare professionals who themselves have a solid clinical knowledge, good education and communication skills, and an understanding of research methodology and how research can be applied to practice. In addition, educational materials can be helpful to make the
most of contact time between the healthcare professional and the individual with diabetes. To help meet the need for education, the Global Partnership has worked with the International Diabetes Federation (IDF) and the Federation of European Nurses in Diabetes (FEND) to develop resources that provide practical guidance to improve treatment for people with type2 diabetes (available at www.fend.org and www.idf.org). People with diabetes may have anxieties about their condition, its future progression and its treatment. Assisting individuals to take control of their condition can help to allay fears. In particular, research suggests that taking a ‘patient-centred’ approach to education can lead to improved outcomes (Fig. 4) [41]. This approach involves a free exchange of information between the healthcare professional and person with diabetes, in an environment that supports a therapeutic consultation. By understanding their daily role as a decision maker, the individual can work with the team so that therapeutic goals and strategies are agreed, based both on standardised targets and on what the individual is able to achieve. The effectiveness of therapeutic education has been demonstrated by a number of studies. For example, when people know their HbA1c values there is evidence that they have a more accurate assessment of their glycaemic control and an increased understanding of diabetes care [42]. In addition, education can lead to an increase in exercise, improvements in
Fig. 4 – The patient-centered approach [41].
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health and reductions in hospital visits [43]. The potential cost benefits have been demonstrated by a study in which implementation of a structured educational programme led to a 62% decrease in the annual cost of medication [44]. Despite this evidence, a survey of physicians in the United States reported that although 98% agreed that educating people with diabetes improved glycaemic control, only 55% reported that they routinely worked with a dietician or a diabetes educator [45]. Education can be an issue for the diabetes management team in terms of time and resources but must be addressed if individuals are to reach their glycaemic goals.
4.
Conclusion
The recommendations of the Global Partnership offer advice for the diabetes management team that is simple, practical and easy to use. The recommendations include advice on achieving optimal glucose control, targeting the underlying pathophysiology of type-2 diabetes, and treating earlier and intensively with combination therapy. Particularly pertinent is the recommendation to adopt a holistic, multidisciplinary approach that improves patients’ understanding of type-2 diabetes. Following these simple recommendations and adapting them to local circumstances offers a route to increasing the proportion of people who reach glycaemic targets, improving outcomes, and reducing the personal and economic burden of type-2 diabetes for the individual and for global society.
Conflict of interest statement Margaret McGill has participated in advisory boards for Novo Nordisk and Sanofi Aventis. Anne-Marie Felton has participated in advisory boards for Novo Nordisk, GlaxoSmithKline and Bayer. Both Margaret McGill and Anne-Marie Felton are members of the Global Partnership for Effective Diabetes Management which is sponsored by GlaxoSmithKline.
Acknowledgements The Global Partnership for Effective Diabetes Management, including development of this manuscript, is sponsored by GlaxoSmithKline plc. The authors wish to acknowledge the editorial assistance of Carol Mason in the development of this manuscript.
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available at www.sciencedirect.com
journal homepage: http://www.intl.elsevierhealth.com/journals/pcd/
Opinion
New global recommendations: A multidisciplinary approach to improving outcomes in diabetes Margaret McGill a,∗ , Anne-Marie Felton b , on behalf of the Global Partnership for Effective Diabetes Management a b
Diabetes Centre, Royal Prince Alfred Hospital, Sydney, NSW, Australia Federation of European Nurses in Diabetes, 24 Holmesdale Avenue, London, SW14 7BQ, UK
a r t i c l e
i n f o
a b s t r a c t
Article history:
Up to two-thirds of people with type-2 diabetes do not achieve glycaemic targets, increasing
Received 21 April 2006
their risk of serious complications. New global recommendations from The Global Partnership
Accepted 28 July 2006
for Effective Diabetes Management offer practical, simple advice for the diabetes management
Published on line 19 December 2006
team to help individuals reach glycaemic goals. The recommendations focus on four areas: achieving optimal glycaemic control, targeting the underlying pathophysiology of the dis-
Keywords:
ease, treating earlier and intensively with combination therapy, and adopting a holistic
Type-2 diabetes mellitus
approach. This article reviews the new recommendations and suggests that they offer a
Hyperglycemia
route to achieving guideline-based targets and improving outcomes in the real-life health-
Diabetes complications
care setting.
Interdisciplinary health team
© 2006 Published by Elsevier Ltd on behalf of Primary Care Diabetes Europe.
Nurses Nurse patient relations Multidisciplinary communication Education
1.
Introduction
The magnitude of the challenge that diabetes presents to health services is strikingly clear. Diabetes is now the fourth or fifth leading cause of death in most developed countries, and with 194 million people suffering from the disease worldwide, its incidence is approaching epidemic proportions [1]. Type2 diabetes, which accounts for around 90–95% of all cases of diabetes [2] is characterised by insulin resistance and is often associated with obesity [3,4]. Consequently, the incidence of type-2 diabetes is projected to increase as populations age,
∗
urbanisation increases, diets become ‘westernised’ and levels of physical activity decrease [5]. By 2030, the International Diabetes Federation predicts that more than 330 million people will have diabetes worldwide [1]. While the direct symptoms of type-2 diabetes, such as thirst, frequent urination and fatigue, can be mild and may cause little interruption to activities of daily living, it is the complications of the disease, including vascular disease, kidney disease and nerve damage, that result in substantial morbidity and mortality. Hospitalisations for complications account for more than half of the healthcare costs of type-
Corresponding author. E-mail address: [email protected] (M. McGill). 1751-9918/$ – see front matter © 2006 Published by Elsevier Ltd on behalf of Primary Care Diabetes Europe. doi:10.1016/j.pcd.2006.07.004
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2 diabetes [6], and three-quarters of people with diabetes die from cardiovascular disease [7]. The development of both micro- and macrovascular complications is associated with elevated blood glucose, with research suggesting that the risk of serious complications increases with the length of time blood glucose is uncontrolled [8,9]. Importantly, evidence shows that people who achieve a period of good control soon after diagnosis of type-2 diabetes have a lower risk of complications later in disease, even if their control subsequently decreases [10–12]. This concept, known as ‘metabolic memory’, suggests that not only is good glycaemic control important, but that good control should be achieved as early as possible. Fundamental to the role of the diabetes multidisciplinary professional management team is the development of initiatives to help people with diabetes achieve glucose goals and reduce the risk of complications. The team must ensure that humanity and continuity of individualised care is central to such initiatives. In recent years, the team structure has changed in many healthcare systems to reflect changes in the model of care. There has been a shift from the traditional, physician-led ‘acute-care model’, in which there is little involvement of the individual with diabetes and team members are often primarily task-oriented, to a ‘chronic care model’, where all members of the team are equal and interdependent, and the person with diabetes plays an active role in daily management. In many, but not all cases, diabetes specialist nurses are the primary point of contact for people with diabetes. Their role is underpinned by increasingly specialised knowledge and skills and, in some systems, the ability to make autonomous diagnoses and treatment decisions. This article reviews new recommendations published by the Global Partnership for Effective Diabetes Management [13], which are designed to help individuals with type-2 diabetes meet glycaemic targets and so improve treatment outcomes.
2. The new recommendations: meeting a need Guidelines around the world generally focus on the importance of achieving HbA1c of 6.0–7.0% [14–18]. However, despite
these guidelines, only one-third of individuals with diabetes reach their recommended HbA1c goal [19,20]. This contrasts with the situation in other areas such as dyslipidaemia, where three-quarters of people reach low density lipoprotein (LDL)-cholesterol treatment goals [21]. The need for optimal glycaemic control is emphasised by results from the EPICNorfolk study, in which the risk of death from all causes, and from heart disease in particular, rose with increasing HbA1c concentration at all levels (Fig. 1) [22]. This study also demonstrated that reducing HbA1c by just 0.2% in the general population could reduce overall mortality by 10% [22]. Therefore, it is clear that more action is needed to improve the proportion of individuals with type-2 diabetes who achieve target glycaemic control, and to enable this to happen as soon as possible after diagnosis. The Global Partnership for Effective Diabetes Management is a group of international diabetes experts that is multidisciplinary and, as such, includes primary-care physicians, specialist nurses and diabetologists amongst its members. The group’s aim is to provide guidance and support for diabetes management teams to help more people reach blood glucose goals. Their recommendations are different because they are the first to be developed specifically to address the gap that exists between current guidelines and implementation in the clinical practice setting by offering practical, easy-to-use advice on how to get people to glucose goals.
2.1.
Barriers to effective glucose control
The new recommendations identify a number of barriers that may account for the proportion of individuals who do not reach glycaemic goals [13]. One major barrier is the fact that diabetes management is traditionally conservative and many prescribers are wary of treating too intensively or using new approaches for fear of side effects. In addition, diabetes is a complex condition for which many treatments exist, polypharmacy is required and it is not always easy to be aware of latest developments. Moreover, prescribers often rely on the ‘stepwise’ approach to treatment, in which management begins with diet and exercise, followed by introduction of monotherapy, increase of the monotherapy to the maximum recommended dose and, finally, combination therapy
Fig. 1 – HbA1c and risk of cardiovascular events or death [22]. A prospective population study of 4662 men and 5570 women aged 45–79 years from the EPIC-Norfolk study. Average follow-up time was 6 years. CHD: coronary heart disease; CVD: cardiovascular disease.
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[23]. However, the stepwise approach can cause unnecessary (or prolonged) delays in reaching glucose goals. Evidence suggests that individuals treated with monotherapy often have HbA1c ≥8% for an average of 14.5–20.5 months before the treatment is changed or a new treatment is added [24,25]. Another barrier is the perception among some prescribers that treatments lack efficacy. While there is a need for efficacious agents, poor adherence, due to a number of financial and behavioural reasons, may contribute to this perception. Adherence to oral glucose-lowering medicines is known often to be lower than in other disease areas, possibly due to: adverse events associated with medication; social, cultural or economic barriers; or a lack of confidence in the benefits of adherence [26]. Moreover, type-2 diabetes is a progressive disease that requires polypharmacy to achieve target blood glucose levels and this concept may not readily be appreciated by some health professionals who persist with advice on lifestyle modification without changes in pharmacotherapy. Also contributing to a perceived lack of efficacy are the logistical difficulties and high demands on time and resources facing healthcare professionals, which can impact on the quality of the patient-provider consultation. A lack of knowledge about the underlying pathophysiology of type-2 diabetes, and particularly, the need to address the insulin resistance that is present in 80–85% of people with type-2 diabetes, can also act as a barrier to glycaemic control [27,28]. Many commonly used therapies that improve glycaemic control on a short-term basis do not address insulin resistance adequately [27–29]. The new recommendations were formulated with these barriers in mind and having considered the pressures on diabetes management teams.
3.
A practical call to action
The 10 key practical recommendations of the Global Partnership are shown in Table 1 [13]. The recommendations cover four key areas: achieving optimal blood glucose control, treating earlier and intensively with combination therapy, targeting the underlying pathophysiology of type-2 diabetes, and adopting a holistic approach that improves patients’ understanding. Uniting the four areas is an underlying sense of urgency about the need to act proactively to bring glycaemia under control. The ability to implement all 10 recommendations may depend
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on the local situation and resources, but the Global Partnership hopes that healthcare professionals will “recognise the importance of tight glycaemic control and implement or adopt as many recommendations as is feasible locally”.
3.1.
Achieving optimal glycaemic control
Current guidelines differ in their recommendations for target glycaemic control [14–18] so the Global Partnership suggests that a universal goal would simplify and improve patient management. Data from the United Kingdom Prospective Diabetes Study (UKPDS) indicated that every 1% drop in HbA1c reduces the overall risk of complications of type-2 diabetes by 21% [9]. Importantly, there was no lower threshold below which a reduction in HbA1c was no longer beneficial. Consequently, the recommendations state that management should aim for HbA1c <6.5%, in line with the latest guidelines from the International Diabetes Federation [30]. They also note the importance of regular monitoring of blood glucose, recommending that HbA1c is monitored every 3 months in addition to regular self-monitoring and that two consecutive measurements of HbA1c ≥7.0% should lead to a review of treatment. Self-monitoring can allow individuals to become more proactive and to improve their glucose control [31], but it is important that results are discussed regularly between members of the diabetes management team so that they are aware of the significance of the results and can assist the individual to take appropriate action.
3.2. Treating earlier and intensively with combination therapy The delays in achieving glycaemic control associated with stepwise management or an over-reliance on lifestyle intervention alone have led the new recommendations to focus on a more proactive approach. They recommend earlier use of combination therapy in parallel with diet and exercise reinforcement. A regimen in which glycaemia is monitored regularly and treatment is reviewed if an individual is not at goal can allow more rapid attainment of glycaemic control and may avoid side effects that are associated with some highdose monotherapies [32,33]. For example, newly-diagnosed individuals should be treated intensively with the aim of achieving HbA1c <6.5% within 6 months of diagnosis. For those
Table 1 – Ten steps to get more type-2 diabetes patients to goal 1 2 3 4 5 6 7 8 9 10
∗
Aim for good glycaemic control, defined as HbA1c < 6.5%* Monitor HbA1c every 3 months in addition to regular glucose self-monitoring Aggressively manage hyperglycaemia, dyslipidaemia and hypertension with the same intensity to obtain the best patient outcome Refer all newly diagnosed patients to a unit specialising in diabetes care where possible Address the underlying pathophysiology, including treatment of insulin resistance Treat patients intensively so as to achieve target HbA1c <6.5%* within 6 months of diagnosis After 3 months, if patients are not at target HbA1c <6.5%* , consider combination therapy Initiate combination therapy or insulin immediately for all patients with HbA1c ≥9% at diagnosis Use combinations of oral antidiabetic medications with complementary mechanisms of action Implement a multi- and inter-disciplinary team approach to diabetes management to encourage patient education and self-care and share responsibility for patients achieving glucose goals
Or fasting/preprandial plasma glucose <110 mg/dl (6.0 mmol/l) where assessment of HbA1c is not possible.
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Fig. 2 – Global Partnership recommendations for management of glycaemia in newly diagnosed individuals [13]. Reproduced from Del Prato S et al. Improving glucose management: ten steps to get more patients with type 2 diabetes to goal. Recommendations from the Global Partnership for Effective Diabetes Management, International Journal of Clinical Practice, with permission from Blackwell Publishing.
who are not at goal after three months, combination therapy should be considered in order to reach the 6-month goal. For individuals who have particularly high blood glucose at diagnosis (HbA1c ≥9%), consideration should be given to initiating combination therapy immediately, or in some cases temporary use of insulin therapy (before transfer to mono- or combination oral therapy) in order to reduce glucose toxicity and reach glycaemic goals as soon as possible. The recommended treatment paradigm for newly-diagnosed individuals is shown in Fig. 2. Lifestyle therapy can be effective and should be an integral component of diabetes care at all times [34]. However, in the real-life setting, adherence to diet and exercise can be difficult to maintain. Because delays in introducing oral monotherapy (often seen with the stepwise approach) can increase the length of time it takes to reach glycaemic goal, the Global Partnership recommends that lifestyle changes are initiated in tandem with pharmacological therapy.
3.3. Targeting the underlying pathophysiology of type-2 diabetes—insulin resistance and progressive ˇ-cell failure The basic pathological mechanisms in type-2 diabetes are insulin resistance leading to pancreatic stress and, in susceptible individuals, consequent pancreatic -cell failure. To date, while glucose-lowering medications are successful in reducing blood glucose levels in the short term, they have not been able to prevent the progressive natural history of type-2 diabetes, as demonstrated by the continual loss of -cell function over time [35]. To optimise chronic glycaemia, the Global Partnership recommends that treatments should address the underlying pathophysiology of the disease to increase insulin sensitivity and/or potentiate insulin secretion. Therapies used in combination should ideally have complementary actions. For example, a thiazolidinedione with a sulphonylurea addresses both defects of insulin resistance and insulin secretion, respectively. Alternatively,
metformin mainly improves hepatic insulin resistance while thiazolidinediones mainly function through adipose tissue and skeletal muscle as insulin-sensitising agents, indicating the value of such a combination [36]. Triple oral therapy with each of these agents also has significant rationale. The comorbidities that contribute to the complications of type-2 diabetes should also be addressed alongside the disease itself. Treating comorbidities with equal priority may redress the balance between the proportion of individuals reaching goals for areas such as LDL-cholesterol and blood pressure, and the relatively low proportion reaching glycaemic goals [19–21]. The Global Partnership recommends that hyperglycaemia, dyslipidaemia and hypertension are managed rigorously with equal intensity to obtain the best outcome.
3.4. Adopting a holistic approach that improves patient understanding The Global Partnership recommends that a multi- and interdisciplinary team approach is the sine qua non of diabetes management, with the aim of encouraging therapeutic, structured patient education and self-care so that responsibility for achieving agreed glucose goals is shared. The key principle of the multidisciplinary team is that all members of the team are equal and interdependent. Hence, there is often some flexibility of professional boundaries, rather than the more distinct roles seen in the hierarchical teams of the past. In the chroniccare model, people undergoing treatment are no longer passive, and instead play an equal and active role in their management and in setting their own goals based on what they want to achieve. The team approach enables continuity of care and self-management and, with adequate communication, all members of the team – including the person with diabetes – can be unified and work towards the same goal. Evidence is building to support the benefits of this model. A study that compared a nurse-led multidisciplinary team (involving a diabetes specialist nurse, psychologist, nutritionist and pharmacist) with standard diabetes care over 6
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Fig. 3 – Impact of a multidisciplinary team [37]. * P < 0.001 compared with control (6-month intervention period). † P = 0.04 compared with control (17–18 months after randomisation). Control: n = 88; multidisciplinary team: n = 97. Copyright ©American Diabetes Association. From Diabetes Care, vol. 22 (1999) 2011–2017. Reprinted with permission from The American Diabetes Association.
months in a primary-care setting found that HbA1c levels decreased by 1.2% with the multidisciplinary approach, but only 0.2% in the control group [37]. During the 17–18 months after randomisation, hospital admissions were 80% lower in the multidisciplinary group (Fig. 3) [37]. Additional research suggests that, if properly implemented, the multidisciplinary approach is cost-effective and improves the quality of diabetes care compared with individual patient-provider care [38]. When a multidisciplinary team approach is taken the exact structure usually varies depending on the local circumstances; however, common to all teams is the position of the person with diabetes at the centre. Ideally, the team will include three or four healthcare professionals with complementary skills: for example, a diabetologist/physician, a diabetes specialist nurse, a dietician and a podiatrist [39]. In some cases the team may extend to include other specialist support services such as cardiologists, exercise physiologists, nephrologists, neurologists, ophthalmologists, wound-care specialists or social workers. In some countries, units that specialise in diabetes care are becoming more common, and evidence suggests that access to such services can increase the proportion of people with diabetes achieving treatment goals and increase survival rates [40]. Consequently, the Global Partnership recommends that all newly diagnosed individuals have access to the variety of clinical and education services offered by a unit specialising in diabetes care where they are available [13]. The continued education and training of all members of the team is an essential component of diabetes care. People with diabetes live with their condition 24 h a day and inevitably undertake 95% of their own care. Consequently, one of the important aims of therapeutic education is to encourage selfmanagement where possible. Individuals must be equipped with the knowledge, skills and confidence to take an active role in managing their condition. Furthermore, people with diabetes should be educated by healthcare professionals who themselves have a solid clinical knowledge, good education and communication skills, and an understanding of research methodology and how research can be applied to practice. In addition, educational materials can be helpful to make the
most of contact time between the healthcare professional and the individual with diabetes. To help meet the need for education, the Global Partnership has worked with the International Diabetes Federation (IDF) and the Federation of European Nurses in Diabetes (FEND) to develop resources that provide practical guidance to improve treatment for people with type2 diabetes (available at www.fend.org and www.idf.org). People with diabetes may have anxieties about their condition, its future progression and its treatment. Assisting individuals to take control of their condition can help to allay fears. In particular, research suggests that taking a ‘patient-centred’ approach to education can lead to improved outcomes (Fig. 4) [41]. This approach involves a free exchange of information between the healthcare professional and person with diabetes, in an environment that supports a therapeutic consultation. By understanding their daily role as a decision maker, the individual can work with the team so that therapeutic goals and strategies are agreed, based both on standardised targets and on what the individual is able to achieve. The effectiveness of therapeutic education has been demonstrated by a number of studies. For example, when people know their HbA1c values there is evidence that they have a more accurate assessment of their glycaemic control and an increased understanding of diabetes care [42]. In addition, education can lead to an increase in exercise, improvements in
Fig. 4 – The patient-centered approach [41].
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health and reductions in hospital visits [43]. The potential cost benefits have been demonstrated by a study in which implementation of a structured educational programme led to a 62% decrease in the annual cost of medication [44]. Despite this evidence, a survey of physicians in the United States reported that although 98% agreed that educating people with diabetes improved glycaemic control, only 55% reported that they routinely worked with a dietician or a diabetes educator [45]. Education can be an issue for the diabetes management team in terms of time and resources but must be addressed if individuals are to reach their glycaemic goals.
4.
Conclusion
The recommendations of the Global Partnership offer advice for the diabetes management team that is simple, practical and easy to use. The recommendations include advice on achieving optimal glucose control, targeting the underlying pathophysiology of type-2 diabetes, and treating earlier and intensively with combination therapy. Particularly pertinent is the recommendation to adopt a holistic, multidisciplinary approach that improves patients’ understanding of type-2 diabetes. Following these simple recommendations and adapting them to local circumstances offers a route to increasing the proportion of people who reach glycaemic targets, improving outcomes, and reducing the personal and economic burden of type-2 diabetes for the individual and for global society.
Conflict of interest statement Margaret McGill has participated in advisory boards for Novo Nordisk and Sanofi Aventis. Anne-Marie Felton has participated in advisory boards for Novo Nordisk, GlaxoSmithKline and Bayer. Both Margaret McGill and Anne-Marie Felton are members of the Global Partnership for Effective Diabetes Management which is sponsored by GlaxoSmithKline.
Acknowledgements The Global Partnership for Effective Diabetes Management, including development of this manuscript, is sponsored by GlaxoSmithKline plc. The authors wish to acknowledge the editorial assistance of Carol Mason in the development of this manuscript.
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